Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects

NCT ID: NCT04586621

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2021-06-29

Brief Summary

The aim of this study is to evaluate the efficacy and safety of a new medical device (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.

Detailed Description

Dyslexia is defined as a specific learning disability that is characterized by reading difficulties, in the absence of intellectual disability, neurological or psychiatric disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency.

Dyslexia appears in the child from the earliest stages of learning in the form of a difficulty in mastering the learning of reading. This disorder is manifested by a generally hesitant reading, slowed down, full of errors, requiring a lot of effort for the child and may impact his reading comprehension. The dyslexia-related deficiency is of variable intensity depending on the individual; it may be accompanied by calculus disorders (dyscalculia), oral language (dysphasia), motor coordination (dyspraxia) or attention disorders with or without hyperactivity. In nearly 40% of cases, a child affected by Dys disorders presents several learning disorders.

To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms and disorders associated with dyslexia does not facilitate the identification of precise neurobiological / psycho cognitive mechanisms. There are therefore several theories: phonological, visual, temporal, cerebellar or proprioceptive auditory processing.

Recently, following work published in 2017, an anatomical cause based on Maxwell's spots could also be a cause of dyslexia.

The aim of this study is to evaluate a new medical device (class I CE marked) to compensate this probable anatomical cause: the Atoldys/ Lexilens glasses

Conditions

Dyslexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Atoldys/ Lexilens - SHAM

Group Type: EXPERIMENTAL

Atoldys/ Lexilens - SHAM

Intervention Type: DEVICE

Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency

SHAM- Atoldys/ Lexilens

Group Type: EXPERIMENTAL

SHAM- Atoldys/ Lexilens

Intervention Type: DEVICE

SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency

Interventions

Atoldys/ Lexilens - SHAM

Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency

Intervention Type: DEVICE

SHAM- Atoldys/ Lexilens

SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Schooled in CM1, CM2 or 6ème,
• French mother tongue,
• For whom developmental dyslexia has been diagnosed by a health professional who specializes in this learning disorder,
• With near vision, without optical correction, equivalent to P5 or better according to the Parinaud scale (distance: 30-40 cm),
• Presenting an IQ ≥ 80 and ≤130 according to the WISC-V test performed by a psychologist,
• For whom a written consent was obtained regarding his study participation.

Exclusion Criteria

• With medical history or presenting a neurological pathology,
• Presenting a developmental disorder (autism, ADHD, ...),
• Presenting hearing disorders,
• Presenting an astigmatism of more than one uncorrected diopter,
• Presenting other visual disorders,
• Any other condition that, in the opinion of health professionals, could impair its ability to complete the study or could pose a significant risk.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Slb Pharma

OTHER

Sponsor Role: collaborator

ABEYE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr Laurence Derieux

Caen, , France

Dr Luc-Marie Virlet

Faumont, , France

CHU Rennes

Rennes, , France

Countries

France

Other Identifiers

Atoldys/ Lexilens

Identifier Type: -

Identifier Source: org_study_id